September 11, 2018 HRPO SeminarRichard Guido, MD, CIP – IRB ChairMelissa Miklos, MSL, CIP – HRPO Associate Director

Why Change from OSIRIS?

• OSIRIS is old (2004)• Extremely customized• Doesn’t play well with others

Huron’s IRB Solution: PittPRO• Increased collaboration:

• Used by 40+ AAHRPP Accredited Institutions• Active User Group to share best practices

• Incorporates regulatory changes as they occur • Common Rule, January 20, 2019

• Includes Library, Toolkit and Help Center to support users• Single IRB Review models

• Cloud-based environment to enable collaborating institutions to see each other’s work

University of Pittsburgh IntegrationCross-system sharing of information with rapid access to data (coming)

Development History

Listened to feedback through lifetime of 

OSIRIS

Collaborated with Huron & University offices on products

Engaged Research Community in early stage development and testing and 

incorporated changes

Limited roll‐out of PittPRO to willing 

researchers for Beta Testing

Roll-Out Plan

• Currently in beta testing: Contact askirb@pitt.edu for access to enter

• Exempt & Expedited undergoing review: 6 approved, 7 in review, 16 in pre-submission

• October 2018: New EE

• Full Board: Beta testing studies expected to go to committee in October 2018

• January 2019: New Full Board Studies

Transition Plan

All active studies in OSIRIS will convert• When: Renewal date

July 1, 2019 or beyond• Enter as a new study; enter

OSIRIS PRO#• Attach paper renewal form• NO modifications at conversion

Can’t Find My Way HomeNavigating your new Home Page and Study Workspace

QUESTIONS?

Home Page: My Inbox

Find Stuff: My Inbox

• Submissions that require your action

• Actions you can perform (create)

• Shortcuts to access other items

Do Stuff

• Review submissions in inbox

• Check the state of items (e.g. Pre‐Submission means you need to finish and submit)

Submit stuff

• “Create new study” to start

• Click on study name to open it 

Navigation and Basic Tasks

Study Workspace

HISTORY shows what has taken place, similar to OSIRIS

CONTACTS: Shows info for all who have access

• Draft document accessible for editing

• Final document with watermarking

• Document History

Combines tab for other submissions into one!

Reviews: Latest Details

Reviews: Shows Ancillary Details

A Picture’s Worth a Thousand Words

Start Me UpSubmitting a new protocol

QUESTIONS?

Start Me Up

Red Star = requiredQ6 & 7: irb.reliance@pitt.eduQ8: Upload protocol or exempt form

Required Sections

Data Security

No longer a separate form

Ancillary Reviews

• Certain of them are selected based on response

• Few can be manually selected• Link to extra info• Gives map to trigger questions• Scientific & Mentor in Pre-

Submission• Others simultaneous in Pre-

Review

Let’s give it a try

Tips, Tricks and ToolsQUESTIONS?

Glossary

Reportable New Information (RNI) = Unanticipated Problems (UAP)Reportable New Information (RNI) = Adverse Events (AE)

Continuing Review (CR) = Renewal

Follow-On Submissions = Continuing ReviewsFollow-On Submissions = Modifications

Electronic Data Management = Data Security

Principal InvestigatorListed on the Basic Info page

Principal InvestigatorDetailed on Study Team Members page

Can’t Touch This

Consent forms MUST be submitted with tracked changesNOT highlighting!

Reunited…and It Feels So Good!

Modifications• Mod “cover sheet”

incorporated into modifiable protocol

• Exempt studies can be modified like any other

One stop to justify modifications-Rationale and support for the change being made

Continuing Review (CR)

Continuing Review: Study Status

Reportable New Information

One RNI: Multiple studies

Reportable New Information

I Still Haven’t Found What I’m Looking For

HELP! I Need Somebody!

412-383-1480Main IRB number

askirb@pitt.eduGeneral IRB questions

rcco@pitt.eduTechnical Issues

Questions?If you need a certificate of attendance, email mgm12@pitt.edu